None listed
Conditions
Brief summary
Difficulty taking deep breaths or coughing are two of the breathing complications people with a neuromuscular disease and weak breathing muscles face. Over time the lungs and rib cage become stiff, lung volumes are reduced and respiratory function is compromised. Such breathing complications are one of the main causes of discomfort, disability and ultimately death in conditions such as Duchenne muscular dystrophy and motor neurone disease. Lung volume recruitment, also known as breath-stacking, is a simple and inexpensive therapy that may help. It involves taking a few breaths in without breathing out, so that a maximum amount of air is held in the lungs before exhaling. This pattern is repeated so that a group of ‘deep breathing exercises’ is performed. A type of resuscitation bag is used to assist each breath. It is thought that performing these breathing exercises daily might prevent chest stiffness, improve breathing capacity and cough effectiveness, however to date there is no strong evidence to support these ideas. This research will look at the short and medium term effects of breath-stacking exercises on the breathing system, by conducting a prospective, single-blinded randomised controlled clinical trial. This means that half of the people who choose to be involved in the study will be asked to perform breath-stacking exercises each day for three months. The other half will be asked to do ‘diaphragm breathing exercises’ (a treatment we don’t believe will have a very big effect). The type of breathing exercise each individual will be asked to do is randomly allocated, i.e. there is a 50:50 chance of being in either group. We will measure lung volumes, stiffness and cough effectiveness by breathing tests, and breathing symptoms and quality of life by questionnaires. These measurements will take place before the person begins, and then 1 month, 2 months and 3 months into the study. We will perform the 1-month and 2-month measurements in the person’s home, to reduce any potential burden or inconvenience. If breath-stacking is beneficial and lung volume, chest stiffness and cough effectiveness improve then symptoms, quality of life and potentially survival are likely to be better. Importantly, this research would add to the recommendations for the respiratory management of people with neuromuscular disorders by providing much needed evidence to support the use of this technique more widely.
Interventions
Treatment group 1: Breath-stacking breathing exercises performed at least twice daily, for 3 months - A routine of deep breaths, augmented using a manual resuscitation bag attached to a mouthpiece or face mask (“MIC breath”), followed by normal breaths is prescribed. The prescription will be tailored to the individual participant, with a treatment aim of 3-5 MIC breaths repeated 3-5 times. Participants will be reviewed by an experienced respiratory physiotherapist who will trial and tailor the breath-stacking routine, then educate and provide instructions for the participant during an individual session of approximately 20 minutes duration at baseline / Visit 1. Adherence will be monitored in both the Intervention group (Treatment group 1) and Active Control (Treatment group 2) using a Participant Diary. Additionally, a data logger attached to the manual resuscitation bag will confirm adherence in Treatment group 1.
Sponsors
Study design
Eligibility
Inclusion criteria
Neuromuscular disease of >3 months duration Respiratory system involvement (FVC <80% predicted)
Exclusion criteria
Previously prescribed daily LVR therapy which was performed for a period of >3 consecutive months in the last 12 months, or >6 consecutive weeks within the past 6 months Medical instability Inpatient admission for acute respiratory compromise in the preceding 6 weeks Inability to provide informed consent Not proficient in English Requiring invasive ventilation via tracheostomy tube Previous history or perceived risk factors for pneumothorax Contraindication or precautions for positive pressure therapy / LVR manoeuvres